MethylPREDNISolone Acetate Injectable Suspension — Class II drug recall D-0499-2024
Ongoing recall by Sagent Pharmaceuticals, reported 2024-05-22, distributed nationwide. Presence of Particulate Matter: Potential for black particulates in the drug product.
| Recall number | D-0499-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals, Schaumburg, IL, United States |
| Recall initiated | 2024-04-25 |
| Classified | 2024-05-15 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 14,360 vials |
| Reason classes | specification failure |
| NDC | 25021-0820, 25021-0820-05, 25021-0820-10, 25021-0821, 25021-0821-05 |
| Lot numbers | 5100186, 5100187, 5100188, 5100189 |
| Expiration dates | 2025-01-31 |
Product
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Reason for recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0499-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.